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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain

Clinicaltrials.gov identifier NCT03944161

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted July 16, 2020

Study Description

Brief summary:

The present study aims to evaluate the use of oral nutritional supplementation in persons with some clinical conditions presenting malnutrition in some extent.

  • Condition or Disease:Nutrition Disorders
    Malnutrition
  • Intervention/Treatment: Dietary Supplement: Oral nutrition supplement
    Other: Nutritional advice
  • Phase: N/A
Detailed Description

COSNUT pretends to assess the cost-effectiveness and cost-utility of oral nutritional supplementation (ONS) in persons with malnutrition and other clinical conditions. The effectiveness will be evaluated by comparing the intervention group having ONS vs a control group only with nutrition advice. The effectiveness and resource use will be collected using quality of life assessment tools, body mass index, change in malnutrition state, number of hospital admissions, medical visits... Unitary costs for Spain will be extracted from databases and official publications and will be applied to the number of resources used in order to calculate the costs in each of the groups. Finally, the incremental cost-effectiveness ratio will be estimated and presented.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 380 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Supportive Care
  • Official Title: Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain
  • Actual Study Start Date: November 2019
  • Estimated Primary Completion Date: October 2020
  • Estimated Study Completion Date: October 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Intervention group
Participants in the intervention group will receive an oral nutrition supplement bottle (200/220 ml) with >20 % of protein and 1.5 Kcal/ml without fibre twice a day during 12 weeks and nutritional advice.
Dietary Supplement: Oral nutrition supplement
Hypercaloric and high protein supplement

Other: Nutritional advice
Advice given by the clinician
Active Comparator: Control group
Participants in the control group will receive nutrition advice
Other: Nutritional advice
Advice given by the clinician
Outcome Measures
  • Primary Outcome Measures: 1. Body mass index [ Time Frame: baseline ]
    Index for relating weight to height. Abbreviated BMI. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared
  • 2. Body mass index [ Time Frame: 12 weeks ]
    Index for relating weight to height. Abbreviated BMI. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared
  • 3. Body mass index [ Time Frame: 6 months ]
    Index for relating weight to height. Abbreviated BMI. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared
  • 4. Change in nutritional status [ Time Frame: from baseline-12 weeks ]
    Change in the Global Subjective Assessment (this scale categorize participants into A, B or C being A the best nutritional status and C the worst.)
  • 5. Change in nutritional status [ Time Frame: from basal-6 months ]
    Change in the Global Subjective Assessment (this scale categorize participants into A, B or C being A the best nutritional status and C the worst.)
  • 6. Number of participants Diagnosed of malnutrition [ Time Frame: from baseline-12 weeks ]
    Diagnosis of malnutrition using GLIM criteria
  • 7. Number of participants Diagnosed of malnutrition [ Time Frame: from baseline-6 months ]
    Diagnosis of malnutrition using GLIM criteria
  • 8. Health related quality of life [ Time Frame: from baseline-12 weeks ]
    EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status)
  • 9. Health related quality of life [ Time Frame: from baseline-6 months ]
    EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status)
  • 10. Functional status [ Time Frame: from baseline-12 weeks ]
    Katz index (this index categorize in one of 7 categories: A,B,C,D,E,F,G from independent for all functions (A) to dependent for all functions (G))
  • 11. Functional status [ Time Frame: from baseline-6 months ]
    Katz index (this index categorize in one of 7 categories: A,B,C,D,E,F,G from independent for all functions (A) to dependent for all functions (G))
  • 12. Strength and endurance [ Time Frame: from baseline-12 weeks ]
    30-second Chair Stand Test
  • 13. Strength and endurance [ Time Frame: from baseline-6 months ]
    30-second Chair Stand Test
  • 14. Strength [ Time Frame: from baseline-12 weeks ]
    hand grip strength test
  • 15. Strength [ Time Frame: from baseline-6 months ]
    hand grip strength test
  • 16. Number of Hospital admittance [ Time Frame: at 30 days ]
    Number of admittance from randomization
  • 17. Number of Hospital admittances [ Time Frame: from randomization to 6 months ]
    Number of admittance from randomization
  • 18. Number of Medical doctor visits [ Time Frame: from randomization to 6 months ]
    Visits to any outpatient medical office
  • Secondary Outcome Measures: 1. Number of deaths [ Time Frame: from randomization to 6 months ]
    mortality registry
  • 2. Number of Infections [ Time Frame: at 6 months ]
    Any diagnosed infection by a medical doctor
  • 3. Number of secondary effects related to the intervention [ Time Frame: from randomization to 6 months ]
    Any undesirable effect due to the intervention
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- >18 y

- Nutritional status B or C (GSA criteria)

- Presenting one of the following conditions:

- Cancer patient after surgery, radiotherapy on antineoplastic treatment.

- Hip fracture

- Heart failure NYHA (New York Heart Association) III-IV.

- Breathing failure GOLD 3 o 4: FEV1 (forced expiratory volume at one second ) <50%. - Renal failure GFR<30 (glomerular filtration rate ) - Participants agreeing the informed consent Exclusion Criteria: - Cancer patients: esophagus, stomach, pancreas and Head and neck - Hospital admitted patients at the time of recruitment - Life expectancy below 3 months - Pregnant or nursing women - Use of oral nutritional supplements in the three months prior the enrolment - History of allergy to oral nutritional supplements - Diabetes mellitus type 1. - Participation in any other study at the time of enrolment - Cognitive limitations to participate in the study

Contacts and Locations
Contacts
Locations

Spain, Andalucía
Complejo Hospitalario Regional Reina Sofía
Córdoba

Spain, Aragón
Hospital Clínico Universitario Lozano Blesa
Zaragoza

Spain, Castilla Y León
Complejo Asistencial Universitario de León
León

Spain, Castilla Y León
Complejo Asistencial de Segovia
Segovia

Spain, Cataluña
Hospital Universitari Germans Trias I Pujol de Badalona
Badalona

Spain, Cataluña
Hospital Universitari Joan Xxiii de Tarragona
Tarragona

Spain, Toledo
Hospital General Nuestra Señora Del Prado
Talavera De La Reina

Sponsors and Collaborators

Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral

WEBER Economía y Salud S.L.

More Information
  • Responsible Party: Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral
  • ClinicalTrials.gov Identifier: NCT03944161 History of Changes
  • Other Study ID Numbers: 01_2019
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: July 16, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral: nutritional supplement
    cost-effectiveness
    cost-utility
  • Additional relevant MeSH terms: Malnutrition Nutrition Disorders